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A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT00194987
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
New York Presbyterian Hospital
Columbia University
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Alloimmune Thrombocytopenia
Fetal Alloimmune Thrombocytopenia
Interventions Drug: IVIG (Intravenous Immunoglobulin)
Drug: prednisone
Enrollment 102
Recruitment Details pregnant women with a fetus affected by FNAIT were enrolled at multiple sites with local IRB permission and local consents fetuses were tracked in utero and after birth for 2 weeks
Pre-assignment Details  
Arm/Group Title Intravenous Gammglobulin (IVIG) 1g/kg Twice Per Week IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
Hide Arm/Group Description

51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.

premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was < 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered

IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was < 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be > 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
Period Title: Overall Study
Started 51 51
Completed 51 48 [1]
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             3
[1]
3 women chose to withdraw because they felt the study was "too inconvenient".
Arm/Group Title IVIG (Intravenous Gamma Globulin) 2g/kg/Week IVIG 1g/kg/wk and Prednisone 0.5mg/kg/Day Total
Hide Arm/Group Description pregnant women with alloimmune thrombocytopenia and a previous affected fetus/newborn and a current affected fetus starting IVIG 2 g/kg/week pregnant women with alloimmune thrombocytopenia and a previous affected fetus/newborn and a current affected fetus starting IVIG 1 g/kg/week + prednisone 0.5mg/kg/day Total of all reporting groups
Overall Number of Baseline Participants 51 51 102
Hide Baseline Analysis Population Description
study describes pregnant women who are receiving treatment but also fetuses and then newborns
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
 100.0%
51
 100.0%
102
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Female
51
 100.0%
51
 100.0%
102
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
United States 48 46 94
Canada 3 5 8
1.Primary Outcome
Title Number of Newborns With a Birth Platelet Count > 50,000/uL
Hide Description this uses the birth platelet count of the fetuses from the study when they are born
Time Frame 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIG 1g/kg Twice Per Week IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
Hide Arm/Group Description:

51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.

premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was < 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered

IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was < 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be > 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: number of newborns with >50,000 pets
48 47
2.Secondary Outcome
Title Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study
Hide Description number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation
Time Frame time of ICH (range 20-40 wks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIG 1g/kg Twice Per Week IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
Hide Arm/Group Description:

51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.

premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was < 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered

IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was < 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be > 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: number of newborns with ICH
0 0
3.Secondary Outcome
Title Number of Fetal Platelet Counts > 50,000/uL
Hide Description Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined
Time Frame 32 +/- 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIG 1g/kg Twice Per Week IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
Hide Arm/Group Description:

51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.

premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was < 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered

IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was < 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be > 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: number newborns with >50,000 pats
44 43
Time Frame collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IVIG X 2 Weekly IVIG 1 g/kg/wk + Prednisone IVIG X 2 Weekly--fetuses/Newborns IVIG x 1 + Prednisone---fetuses/Newborns
Hide Arm/Group Description

Intravenous Immunoglobulin (IVIG) one gram per kg bodyweight infused twice weekly to mothers during pregnancy

fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth

intravenous gammaglobulin 1 g/kg/wk infused once weekly to mother and prednisone 0.5 mg/kg/day taken by mothers during pregnancy and then tapered after birth fo newborn

fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth

fetuses and newborns of mother receiving IVIG x 2 weekly fetuses and newborns of mother receiving IVIG x 1 weekly + prednisone 0.5mg/kg daily
All-Cause Mortality
IVIG X 2 Weekly IVIG 1 g/kg/wk + Prednisone IVIG X 2 Weekly--fetuses/Newborns IVIG x 1 + Prednisone---fetuses/Newborns
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/51 (0.00%)      0/51 (0.00%)      0/51 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
IVIG X 2 Weekly IVIG 1 g/kg/wk + Prednisone IVIG X 2 Weekly--fetuses/Newborns IVIG x 1 + Prednisone---fetuses/Newborns
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/51 (27.45%)      12/51 (23.53%)      4/51 (7.84%)      3/51 (5.88%)    
Blood and lymphatic system disorders         
thrombosis, venous * [1]  1/51 (1.96%)  1 0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0
Endocrine disorders         
gestational diabetes * [2]  2/51 (3.92%)  2 4/51 (7.84%)  4 0/51 (0.00%)  0 0/51 (0.00%)  0
diabetes mellitus *  0/51 (0.00%)  0 3/51 (5.88%)  3 0/51 (0.00%)  0 0/51 (0.00%)  0
Infections and infestations         
amnionitis *  1/51 (1.96%)  1 0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0
neonatal sepsis * [3]  0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0
Nervous system disorders         
headache * [4]  4/51 (7.84%)  4 2/51 (3.92%)  2 0/51 (0.00%)  0 0/51 (0.00%)  0
fetal ICH  [5]  0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
preterm labor *  5/51 (9.80%)  5 2/51 (3.92%)  2 0/51 (0.00%)  0 0/51 (0.00%)  0
HELLP * [6]  1/51 (1.96%)  1 0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0
premature delivery  [7]  4/51 (7.84%)  4 3/51 (5.88%)  3 4/51 (7.84%)  4 3/51 (5.88%)  3
Psychiatric disorders         
depression *  1/51 (1.96%)  1 1/51 (1.96%)  1 0/51 (0.00%)  0 0/51 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Peripheral Intravenous Catheter thrombosis
[2]
requiring hospitalization
[3]
sepsis in newborn
[4]
1 aseptic meningitis
Indicates events were collected by systematic assessment
[5]
Intracranial hemorrhage occurring in fetus
[6]
hypertension liver low platelets
[7]
delivery prior to 35 weeks of gestation
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IVIG X 2 Weekly IVIG 1 g/kg/wk + Prednisone IVIG X 2 Weekly--fetuses/Newborns IVIG x 1 + Prednisone---fetuses/Newborns
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/51 (23.53%)      8/51 (15.69%)      0/51 (0.00%)      0/51 (0.00%)    
Endocrine disorders         
diabetes mellitus *  0/51 (0.00%)  0 2/51 (3.92%)  2 0/51 (0.00%)  0 0/51 (0.00%)  0
neonatal hypoglycemia * [1]  0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0
Musculoskeletal and connective tissue disorders         
jaw tightness * [2]  1/51 (1.96%)  1 0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0
Nervous system disorders         
bells palsy *  1/51 (1.96%)  1 0/51 (0.00%)  0 0/51 (0.00%)  0 0/51 (0.00%)  0
headache *  5/51 (9.80%)  5 2/51 (3.92%)  2 0/51 (0.00%)  0 0/51 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
hypertension *  3/51 (5.88%)  3 2/51 (3.92%)  2 0/51 (0.00%)  0 0/51 (0.00%)  0
Product Issues         
IVIG dose error * [3]  2/51 (3.92%)  2 2/51 (3.92%)  2 0/51 (0.00%)  0 0/51 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
low blood sugar in newborn
[2]
past history
[3]
once each: 10 grams and 120 grams
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr James Bussel
Organization: Weill MC
Phone: 917-291-5091
EMail: jbussel@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00194987     History of Changes
Other Study ID Numbers: 0102004801
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: August 10, 2018
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018